DACLIZUMAB

DACLIZUMAb
(dac'li-zu-mab)
Zenapax
Classifications: biologic response modifier; monoclonal antibody; immunosuppressant; interleukin-2 (il-2) receptor antagonist;
Therapeutic:immunosuppressant; monoclonal antibody

Pregnancy Category: C

Availability

5 mg/mL injection

Action

Immunosuppressant IgG-1 monoclonal antibody produced by recombinant DNA technology. Binds to interleukin-2 (IL-2) receptor complex of lymphocytes.

Therapeutic Effect

Daclizumab inhibits IL-2–mediated activation of lymphocytes which is the major pathway for cellular immune rejection of allografts.

Uses

Prophylaxis of acute organ rejection in renal transplant.

Contraindications

Hypersensitivity to daclizumab; murine protein hypersensitivity, pregnancy (category C), lactation.

Cautious Use

Moderate-to-severe renal impairment; allergies, asthma, or history of allergic responses to medications; fungal or herpes infection, lymphoma, neoplastic disease, vaccination, varicella, viral infection.

Route & Dosage

Renal Transplant
Adult/Child (>11 mo): IV 1 mg/kg. Start first dose no more than 24 h prior to transplant; repeat q14d for 4 more doses

Administration

Intravenous

PREPARE: IV Infusion: Add calculated amount of drug (based on patient's body weight) to 50 mL of NS. Invert infusion bag to dissolve, but do not shake. Discard if diluted solution is colored or has particulate matter.  

ADMINISTER: IV Infusion: Infuse diluted drug over 15 min.  

  • Use diluted solution immediately or store at room temperature for 4 h or at 2°–8° C (36°–46° F) for 24 h. Discard after 24 h.
  • Store unopened vials at 2°–8° C (36°–46° F) and protect from light.

Adverse Effects (≥1%)

Body as a Whole: Edema (general and in extremities), pain, fever, fatigue, shivering, generalized weakness, arthralgia, myalgia, hypersensitivity reactions. CNS: Tremor, headache, dizziness, insomnia, anxiety, depression. CV: Chest pain, hypertension, hypotension, tachycardia, thrombosis, bleeding. GI: Constipation, nausea, diarrhea, vomiting, abdominal pain, dyspepsia, abdominal distention, epigastric pain, flatulence, gastritis, hemorrhoids. Urogenital: Oliguria, dysuria, renal tubular necrosis, hydronephrosis, urinary tract bleeding, renal insufficiency. Respiratory: Dyspnea, pulmonary edema, cough, atelectasis, congestion, pharyngitis, rhinitis, hypoxia, rales, abnormal breath sounds, pleural effusion. Skin: Impaired wound healing, acne, pruritus, hirsutism, rash, night sweats. Other: Diabetes mellitus, dehydration, blurred vision.

Interactions

Drug: Mycophenolate, cyclosporine may increase mortality.

Pharmacokinetics

Duration: 120 d. Half-Life: 20 d (11–38 d).

Nursing Implications

Assessment & Drug Effects

  • Monitor carefully for and immediately report S&S of opportunistic infection or anaphylactoid reaction (see Appendix F).

Patient & Family Education

  • Use effective contraception before beginning daclizumab therapy, during therapy, and for 4 mo after completion of therapy.
  • Avoid vaccinations during daclizumab therapy.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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